QC Environmental Monitoring Team Leader

仕事内容

Make your mark for patientsWe are looking for a Quality Control Environmental Monitoring Team Leader who is to support on time sampling & testing of environmental monitoring of our production area & utilities distribution networks, sharing with the team his high-level scientific expertise and experience to join us in our Quality Control EM (environmental monitoring) & Microbiology laboratory team, based in our Braine-l’Alleud campus in Walloon Brabant, Belgium.About The RoleAs our new team member, you:

• Manage and empower the technicians/samplers team of the QC Environmental Monitoring laboratory to ensure sampling and analyses of environmental monitoring of our production areas, utilities distribution networks
• Ensure that monitoring program is applied and respected (frequency, sampling,...).
• Trend the results of environmental monitoring of production area and communicate to stakeholders (production, QA,…)
• Increase expertise in the laboratory by training technicians/samplers to analytical techniques as well as laboratory/sampling good practices and support troubleshooting
• Lead Pharmacopeia requirements for the QC environmental monitoring team (i.e., update templates, LIMS requirements and trainings documentation, support troubleshooting, review Pharmacopeia updates vs QC practices, etc)
• Coordinate all requests of analysis asked by the stakeholders, ensure the follow-up and communicate the results
• Prepare, verify, and communicate the weekly planning of the technicians/samplers
• Participate to all meetings with stakeholders in term of planning and samples follow-up
• Support projects, deviations, and investigations within the laboratory

What You’ll Do

• Apply the company’s Health and Safety policy within the laboratory
• Ensure a safe working environment to meet site safety objectives especially for the samplers
• Motivate, recognize team members performance, behaviors and compliance of rules whilst firmly supporting teamwork and spirit
• Manage conflicts
• Increase team’s competency by ensuring adequate training, coaching and development of technicians in function of the team and people potentials
• Define and communicate openly the objectives of individuals and of the team in accordance with the company’s strategy and formally assess the results with the adequate KPI (Key Performance Indicators) covering HSE, quality and overall performance both for the individuals and the team
• Ensure continuous feedback: technicians, peers, management, and stakeholders
• Ensure job descriptions & training plan of people are in line with the QC organization
• Ensure the day-to-day operational planning and coordination to satisfy the stakeholder/client needs based on a monthly forecast
• Organize daily meetings with team (Tier 1) to follow-up on the planning and collect and give information. Ensure that each one contribution is done in due time
• Ensure required corrective actions are taken and put in force
• Implement, follow-up and communicate on KPI with its related corrective actions
• Inform stakeholders and responsible of the lab if deviations from the day-to-day-planning occur
• Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity to ensure adherence to plan and performance
• Ensure that continuous improvement is part of day-to-day activities of the team
• Ensure that the lab infrastructure including facilities, utilities and equipment are well maintained
• Maximize the use of departments budget within given budget limits
• Be accountable for a pro-active collaboration with different stakeholders
• Ensure follow-up and compliance of procedures and instructions, and update if needed
• Ensure follow-up of corrective actions and preventive actions
• Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits
• Ensure the follow-up of OOS/OOT and take actions to reduce the number of laboratories/sampling OOS/OOT
• Ensure adequate training/coaching of technicians/samplers linked to the activities requested and performed

Interested? For this role we’re looking for the following education, experience and skills

• You have a Master or a graduate degree required in bioengineering, microbiology, molecular biology, analytical chemistry applied to aseptic and/or biological products or equivalent with demonstrated experience in environmental monitoring.
• You have 5 years or more of expertise in industry related to aseptic activities
• You have 2 years or more of expertise in the pharmaceutical analysis (i.e. raw material, utilities,….)
• You have 2 years or more of Team management experience
• You have expertise in Pharmacopeia methods, implementation requirements, and troubleshooting
• You have expertise/training in microbiology
• You have project leadership skills that includes planning, monitoring, issue resolution, investigations (DMAIC, 5M, etc), decision making and reporting
• You have proven experience in GMP environment
• Ideally, you have experience on the use of LIMS software for sample management
• You have proven experience in audit preparation and audit defense
• Ideally, you have proven experience on the use of Trackwise or equivalent software for deviation management, change control implementation, CAPA, etc is an asset
• Green or Yellow belt ownership is an asset
• You have Data management knowledge (i.e., graphic generation, data comparison, etc)
• Implementation and maintenance of 5S mindset and environment is an asset
• You have a “Green” mindset
• You speak and write on a professional level in French and English

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work for us?At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.